KR20030026359A - Minimally-invasive medical retrieval device - Google Patents

Abstract

The medical retrieval device includes an elongated cylindrical member having a passage extending therein and has a metallic proximal and distal portions. This proximal and distal portions are formed of separate fragments and are connected at the junction. The elongated cylindrical member has a substantially constant inner and outer diameter, at least in part of the proximal portion very close to the junction, through this junction to the portion of the distal portion very close to the junction.

Description

Medical micro-insertion recovery device {MINIMALLY-INVASIVE MEDICAL RETRIEVAL DEVICE}

Stones (calculi) are likely to develop in various organs and tubes. Gallstones are at least a common problem in the United States and are the most frequent cause of gallbladder inflammation. Absences are also common in other parts of the biliary system. Likewise, stones can develop throughout the kidney or urinary tract in the ureters and distals thereof, as well as in the renal tubules and the major and mimor renal calyxes. Calyxes are hollow collecting structures in the kidneys, following the renal pelvis, and small embryos, in particular, join the renal pyramids. Simply, the embryo may be considered a conduit that extends from the connecting tubules of the nephrons of the kidney to the ureters.

Microsurgery procedures have been developed to remove stones in the bile duct and urinary system. This procedure may use percutaneous access instead of performing an open invasive surgical procedure (such as cholecystectomy, for example), and absents may be used as a percutaneous access sheath. Is removed through. Some approaches are appropriate for the particular location of the particular organ and the organ where the absence is found. Regardless of the approach, however, percutaneous removal is usually based on the use of tweezers or basketed catheters to bind and remove stones.

A closed, tipped wire (helical or straight wire) basket allows stones, etc., to enter from the side, while an open ended basket allows frontal access to the stones, etc. Other retrievers and grasper may be tweezers or may comprise a ring or snare for enclosing the body to be removed, which loop or snare is for example circular or flat. ) Is made of wire. Balanced wires have the advantage over baskets that, in use, have a better resistance to twisting of the basket incorporating the balanced wires. In addition, with the development of surgical techniques and the development of relatively small diameter endoscope channels, efforts to reduce the diameter of the circular wires used for the removal of stones were unfortunately unsuccessful. In fact, the lowest effective diameter of a circular wire is still about 0.007 to 0.010 in. (About 0.178 to 0.254 mm). Since there is a great deal of wasted space inside the sheath or cannula with round or balanced wires, this limit of wire effective diameter is small in diameter, especially the outer diameter (ie the diameter of the sheath or cannula with wire). ) Inhibits the development of an effective stone extractor with a height of about 1.7 French (0.022 in. Or 0.56 mm) or less.

Another desirable feature of small recovery devices, especially those that are important for urological use, is to have devices that work with small diameter endoscopes, such as ureteroscopes, ie laser fibers that break stones for easier removal. Or accessory devices such as hydraulic lithotripsy wire. With a limited spacing and number of lumens effective to a small extent, it would be advantageous to make a device capable of sharing the end channel of the endoscope without increasing the diameter of the scope internal lumen. Some smaller diameter retrievals can be introduced through the ureteroscope, the size and design of the wires prevents the accessory instruments for performing the crushing procedure from having internal lumens that can be retracted into the reclaimer's workspace.

FIELD OF THE INVENTION The present invention generally relates to medical devices for binding or removing medical devices, in particular subjects such as calculi on the body.

1 is a view of the medical recovery apparatus of the present invention;

2 is a side view of FIG. 1 in an undeployed or rigid state;

3 is a side view of an alternative embodiment of the device of the present invention including forceps tweezers in an undeployed state;

4 is a cross-sectional view of the device of FIG. 2 across line 4-4;

FIG. 5 is a cross-sectional view of the device of the alternative embodiment of FIG. 3 across line 5-5 of FIG. 3, formed of a rigid member and showing a wedge-shaped elastic forceps member; FIG.

6 is a cross-sectional view of the optional embodiment of FIG. 3 across line 6-6 of FIG. 3 in which the optional embodiment is formed of a rigid member having a distal end bore;

7 is a side view of the device of FIG. 3 in an deployed state;

8 is an illustration of the device of FIG. 1 using an endoscope to find and mill stones;

9 is an illustration of an alternative embodiment of the device of the present invention including a snare;

10-11 are side views of optional embodiments of the device of the present invention, wherein the distal end of the device includes a rigid tip;

12 is a side view of the device of FIG. 1 with the trapped stone blocked;

13 is a cross-sectional view of an optional embodiment of the present invention in which the device comprises three elastic forceps members;

14 is a cross sectional view of another alternative embodiment of the present invention having eight elastic forceps members;

15 is a side view of another alternative embodiment of the present invention in which the device comprises a helical recovery basket;

16 is a side view of the device of FIG. 15 in an deployed state;

17 is an illustration of another optional embodiment of the present invention in which the device comprises an actuating member;

18 is a view of the device of FIG. 17 in a blocked state catching a stone;

19-21 illustrate another embodiment of the present invention in which the elastic tongs of the device comprise strips or wires of one material exposed from within the tube wall of another material;

FIG. 22 is an illustration of another embodiment of the present invention in which the device of FIG. 1 is shown having a junction between the distal and proximal portions of the elongate member or shaft; FIG.

FIG. 23 is an enlarged partial elevation view of the device of FIG. 22 showing the junction between the distal portion and the shaft; FIG.

24 is a cross sectional view of the device of FIG. 22 through the 24-24 line of FIG. 23;

FIG. 25 is a longitudinal cross-sectional view of the device of FIG. 22 through line 25-25 of FIG. 23;

26 is a view of the device of FIGS. 1-25 with a laser device or crushed stone device and a handle used;

FIG. 27 is a sectional view of the handle of FIG. 26; FIG.

* Code Description *

10: medical recovery device 11: extension member

13: elastic forceps member 24: absent

31: reinforcing wire 33, 71: braided

44: scope 46: subchannel

54,69: basket 55: distal cylinder

60: cannula 63: shaft

86: handle 88: sliding member

90: protrusion 98: handle body

The above-mentioned problems have been solved and technological advances have been made in the exemplary medical retrieval device, which is particularly useful for endoscopes for binding, catching, breaking, moving, extracting or retrieving objects such as stones, gallstones and foreign bodies at various locations in the body. The disclosed embodiments of the current medical retrieval device each have an elongate member, wherein the elastic forceps member distal to the elongate member is an example of a continuous material comprising at least part of the elongated member. The proximal portion of the elongate member may be made of the same or different material as the continuum including the forceps member and the distal portion of the elongate member. The elastic member constitutes a basket or tweezers.

In one embodiment of the invention, the individual tong members slot or slitting the distal portion of the elongate member longitudinally with respect to one end. The distal portion of the elongate member may be a hollow cannula or a rigid member, preferably cylindrical. The slot is made by removing material from the distal portion of the extended extension member of the longitudinally extending slot. An elastic forceps member arises in the vicinity of the circumference of the elongate member with residual material thereon. Optionally, this member is created by removing material that exposes an element, such as a reinforcing wire, already inserted inside the wall of the elongate member. Advantageously these members may comprise a basket or snare when the tong members are interconnected at the distal end of the device or may include tong tweezers when they are not connected.

The methodology for making the basket involves attaching the basket wire to a shaft piece that has already been soldered, welded, crimped or otherwise separated. Due to the distal portion of the elongate member and the continuous wire or resilient tweezer member, the joint is advantageously excluded at the basket wire ends. Such a seam can be fragile and can result in a dangerous situation where broken wires are present inside the patient. Other advantages of the retrieval baskets, tongs or tweezers of the present invention made of thin wall cannula or tubing are wide open lumens and relatively small outer diameters. This large open lumen advantageously allows the crushed stone procedure to be performed when the recovery device is inserted through the ureteroscope. The present invention is particularly advantageous over the prior art in that the device has an overall outer diameter that is much smaller than the outer diameter of the current retrieval or extraction device, in that the seam between the wire and the shaft increases the outer diameter and / or the inner diameter of the lumen available. . The recovery device of the present invention may have an outer diameter as small as 1 French (0.33 mm), although 2-3French (0.667-1.0 mm) is the preferred size for use with respect to ureteroscopes and laser fibers or crushed laser fibers. . Small devices can reach deep into the body to capture and recover stones. It goes without saying that the small diameter is also expected to reduce the risk of inadvertent damage and unpleasant feeling to the tissue during insertion and manipulation of the device in the patient.

When using a recovery device, visualization of the target object is essential. Endoscopy, which is used for the maximum microinsertion procedure to recover stones, generally has a second or third accessory channel or lumen to insert the accessory into the treatment location. Small diameter endoscopes, such as ureteroscopes, have a very narrow accessory channel into which the retrieval device enters. An advantage of the present invention is that the design of a tube with a wide central lumen is an absent or useful device useful for procedures such as guidewires for placement, such as laser fibers or electrohydraulic lithotripsy wires. To crush. Conventional basket or tong tweezers manufacturing techniques that require soldering the basket wire to the shaft of the device or making the basket wire a narrow diameter do not leave enough additional space for other devices in the narrow operating channel. While the central lumen is useful for inserting the instrument into the internal operating area, alternative embodiments are filled with solder to fill the end of the cannula or other material that forms a less traumatic tip to the tissue.

Another further advantage of the present invention lies in the relatively simple structure. Devices composed of metal cannula or cylinder may be formed by creating a series of longitudinal slots or slits through cannula / cylinders forming individual resilient tong members. This procedure does not take into account the skilled manual work required to assemble a basket or tong tweezers, other than to perfectly align the tong member and to correct the tong member. Plastic deformation or heat setting of the elastic forceps member to the outwardly extending configuration of the basket or tweezers eliminates bending stress and leaves it in a relaxed state during deployment of the expanded device. The recovery device of the present invention may use an external constraining mechanism, such as a coaxial external sheath or endoscope, that opens and closes an elastic forceps member that captures and retrieves a target object to be removed from the patient. Optional methods may include an actuating member disposed within the lumen of the basket or forceps tweezers opening and closing device or forming only one slot or slit from the distal end to the side wall.

In another embodiment of the present invention, the recovery device is formed from an elongate member consisting of a plastic tube with a reinforcing wire contained therein. These wires, each representing a longitudinally extending continuous material of the distal portion of the elongate member, are exposed in the distal portion of the tube interconnecting them, from which they are formed up to an elastic forceps member for making a recovery basket or forceps tweezers. Factors affecting the ability of the collector to percutaneously bind or remove stones, such as the strength of the equipment tongs to retain and remove stones, and large size to remove and protect the equipment from the energy used to break the stones Has the ability to break up stones. The use of lasers or other crushed stone devices also requires a large central lumen through which clad fiberoptic cables handle the stones. Baskets or tongs made of metals such as stainless steel of the 300 or 400 series or nickel-titanium alloys such as nitinol and having a metal shaft extending behind the proximal end forming the central lumen, handle stones in the patient's body The metal structure extending from the proximal end of the device to the tongs or distal end of the basket and enclosing the central lumen is characterized by an endoscope with laser energy that may be misdirected due to a defect in the laser fiber. Protect the surrounding tissues. Defects, such as nicks in the fiber, direct laser energy towards the sidewall of the endoscope, causing damage to the instrument and loss of function. Lightweight flexible materials, such as coated wire braids including metal structures and proximal ends for the distal portion of the elongate member, or shafts can overcome these difficulties for removing stones from the patient's body. .

When the second material is used in the proximal portion of the elongate member or recovery device shaft, this second material may be selected because of its flexibility, cost and strength. The shaft made of the second material is attached to the distal portion of the elongate member with the tong member forming a multi-part recovery device. The retrieval device of the present invention may use an external suppression mechanism, such as a coaxial external sheath or endoscope, which opens and closes the elastic forceps member to capture and retain the target object for removal from the patient. Optionally, the methods may include an actuating member disposed in the lumen of the basket or forceps tweezers opening and closing device.

In one embodiment of the invention, the retrieval device is made of two parts, each of the proximal (or shaft) and distal portions of the elongate member having a passage extending from end to end. These portions are attached to form a device having respective passages concentric with each other to form a central continuous lumen through the entire recovery device from the proximal end of the shaft to the region closest to the basket, tongs or tweezers. This central lumen is used to extend the fiber optic wire or the crushed wire from a power source controlled by an inductor outside the patient to the position closest to the subject under the control of a basket, tongs or tweezers.

Embodiments of the present invention will be described as an example with reference to the accompanying drawings:

Medical recovery apparatus 10 of the present invention, as shown in Figure 1, consists of an extension member 11 including a distal portion 37 and a proximal portion 21. The distal portion 37 includes a plurality of elastic forceps members 13 formed to have a workspace size, which provides a workspace for capturing and handling objects. The distal portion 37 of the elongate cylinder member 11 is continuous, rather than connected by elements of a single material (or dissimilar material) that are soldered, crimped or otherwise joined, or consisting of two or more distinguishable elements. Continuous single material 40 such as stainless steel or nickel-titanium alloy.

In the embodiments shown in FIGS. 1-18, the first series of materials is a single cannula 60 in which a medical recovery device 10 is formed, such as a basket 54, forceps tweezers 23, or snare 26. Or a rigid rod 62. Although it is preferred to use a circular or otherwise cylindrical cannula or rod, the elongate member 11 may have a polygonal or other non-circular cross section. The first series of materials 40 is preferably composed of an elastic material suitable for forming the elastic forceps member. Other elastic materials may be used that can maintain bending stress and return to elastically preformed rolls. Metals are the preferred materials for making medical recovery devices 10 together with alloys or stainless steels with superelastic properties such as commercially available nickel-titanium alloys such as NiTiol, the most preferred material. Preferred stainless steel will be one of the 300 series with the 400 series also providing a substitute. Any polymeric material with sufficient modulus of elasticity can be used in larger size devices. Superelastic materials such as nitinol are preferred for small devices with thin wall thicknesses (less than 4 Fr. (1.33 mm)) because of improved resistance to fracture or kiniing.

The preferred method of forming the elastic forceps member 13 from the distal portion 37 of the extension member is to create a slot 15 or slit, or an open area or space between the elastic forceps members 13, To remove the material. In the exemplary embodiment, the four elastic tongs 13 are secured by the cannula (e.g., by securing the slot 15 past the wall 16 of the distal portion 37 of the elongate member 11, especially in the cannula 60). 60).

2 is a side view of the cannula 60 showing the distal portion 37 of the elongate member 11 prior to reshaping the elastic forceps member. 4 is a cross-sectional view of the device of FIG. 2 through lines 4-4. The same number of slots 15 as the preferred elastic forceps member are integrated with the wall portion 16 of the elongate member. When the hollow metal cannula 60 is used as in the illustrated embodiment, unnecessary material between the elastic forceps members 13 can be removed by cutting means such as a standard EDM wire machine or a laser. Alternative methods are water jet, machining or chemical corrosion. When an EDM wire machine is used, pilot holes for continuous EDM wires are drilled in the elongate member 11. The diameter of the cutting wire or laser determines the width of the slot 15 and, as a result, the width, thickness and / or diameter of the elastic forceps member 13. An alternative method of cutting a slot into a cannula is to insert a rod and then cut a laser (or other similarly similar performance) to cut a predetermined depth that prevents the inserted rod from extending over the opposing face of the cannula 60. Cutting mechanism). Another method is to make slots, gaps or openings during the initial assembly of the elongate member 11, especially in the case of devices made of plastic. In an exemplary embodiment, the slot 15 is closed distal cylinder 55 like a closed proximal cylinder 19 that includes the proximal end of the distal portion 37 when terminating the ends of the proximal ends of the forceps member 13. Ends ahead of the distal end 20 of the elongate member 11, leaving. The closed distal cylinder 55 provides a means for engaging the distal end 41 of the elastic forceps member without considering the need for separate coupling, such as solder joints or crimping devices.

After the longitudinal slots 15 are formed for the first time, the elastic forceps member 13 is a compact 17 which is essentially parallel to the longitudinal axis 43 of the elongate member. In the embodiment of the cannula 60, which is a compact or compressed form 17, as shown in FIG. 4, the original diameter and the maximum lumen size without essentially increasing the overall diameter of the recovery device 10. Produces an extension member 11 having a. Returning to FIG. 1, the basket 54 has a second outwardly developed shape 18 which creates a workspace size 28 between the outwardly protruding tong members that the stones may take to retrieve or manipulate. It is formed by plastically deforming the individual elastic forceps member (13). The tong members are provided with an open area for capturing an object, such as an arcuate widened portion of FIG. 1 or an angled overhang created by inserting a bend 61 into the elastic forceps member 13 as shown in the embodiment of FIG. 17. It can be any other shape to make.

Referring also to FIG. 1, if the recovery device 10 of the present invention is made of nitinol instead of stainless steel, the slot 15 is cut and the elastic forceps member 13 has a mandrel or It is formed into a mold 18 that is widened using a fixture. The bending stress of the elastic forceps member is then eliminated, at which point the device is heat set or "polished" with the widened mold 18. For example, the temperature for fixing the finished device to heat is 500 ° C. or higher. The deformation temperature that changes from the martensitic state of the material to the shape memory austenite state is such that the elastic forceps member has sufficient resilience to maintain its shape and function as a recovery device. Should be below the temperature used. This temperature may be set below room temperature, ie 10 ° C., or may be set to a temperature between room temperature and body temperature so that the device is easily loaded into an external sheath when in the martensite state. An alternative method of forming vents with nitinol is plastic deformation of the material by a method known as cold working, as shown in PCT Publication No. WO00 / 33909. Nitinol is a local phase change that is mechanically overstressed, creating a permanent bend at that point.

An external retaining mechanism 14, such as a coaxial outer sheath, is used as shown in FIG. When it is important to minimize the overall size of the device, it is of course also important to select the smallest sheath 14 that allows the elongated cylindrical member 11 to move axially. In order to reduce the friction between the elongated cylindrical member 11 and the external containment mechanism 14, the outer surface of the shaft 63 of the recovery device 10 is made of a thin material of slippery material such as polytetrafluoroethylene (PTFE). It is advantageous to add the membrane 35.

12 shows a side view of the device of FIG. 1 in a closed state 30 with trapped stones 24. In the absence of stones 24 or other trapped objects, the substantially closed state 30 will be essentially the same as the solid state of FIG. 2. The outer restraint mechanism 14 is advanced upwards to the elastic forceps member 13, and the elastic forceps from the proximal end 39 until the elastic forceps member 13 firmly secures the stones in the compressed workspace size 28. The member 13 is elastically deformed or radially compressed. If desired, recovery device 10 and recovery object 24 may then be removed together from the body.

FIG. 3 shows a side view of an alternative embodiment of the retrieval device 10 of FIG. 1 comprising a series of forceps tweezers 23 having an elastic forceps member 13 in a compact form 17. The forceps tweezers are made essentially the same as the device of FIG. 1 except that the slot 15 extends into the distal end 20 of the elongate member 11. As with the manufacture of the basket, the elastic forceps members are plastically deformed or heat fixed in the open state 18, as shown in FIG. 7, to receive the target from the patient. To facilitate capturing and holding the target, the distal tip 36 of the elastic forceps member is bent inward. The elastic forceps member catches the target object with an external suppression mechanism 14 that is advanced in the same manner as the basket 54 of FIG.

8 is a view of the recovery device 10 of FIG. 1 showing how it may be used with the ureteroscope 44. In order to remove stones in the urinary tract, an optical lens 45 is usually connected to an optical fiber or series of lenses making the target visible, a light source 53 for illumination and at least one accessory channel for insertion of the instrument A standard ureteroscope 44 is used that includes 46 and / or passages of fluid. A typical ureteroscope accessory channel 46 may range from 2.0 Fr (0.677 mm) to at least 6 Fr (2 mm). An exemplary embodiment with an outer diameter of about 3 Fr (1 mm) may be used with an accessory channel of 3.4 Fr (1.133 mm). The outer diameter of the compression basket 54 or the elongated cylindrical member 11 is about 2.5 Fr (.833 mm) with a passage 12 of about 2 Fr (0.66 mm) in diameter. This passage or lumen 12 can adapt a standard laser crushed wire that is about 200 microns in diameter, except for cladding. This laser delivers energy to the stones 24 and breaks them up into small pieces that can pass through the ureters or exit the passages 12 of the device. While the use of a small retrieval device 10 allows an advantageous passage through an endoscope, embodiments of the large baskets or tweezers of the present invention, such as 9 Fr (3 mm) or larger, require a large central lumen as well as in the body. It is believed that it can be utilized in general recovery applications wherever possible.

Another benefit of forming the recovery device 10 from the cannula is to create an arcuate cross-sectional shape of the elastic forceps member (as shown in FIGS. 4 and 6). Elastic tong members of the arcuate cross section and flat or bar-like cross sections of the same size and material are given, with individual arcuate cross-section elastic tongs empirically exerting approximately 25% or more of force to the target. It is shown that it can add. These structural advantages described are similar to those of I-beams used in girder design in construction due to their superior strength.

In addition to being made from cannula, the basket and tong tweezers of the present invention can be made from a rigid extension member. FIG. 5 shows a cross-sectional view of the elongated cylindrical member 11 through line 5-5 of FIG. 3, which is an alternative embodiment formed of a rigid member and having a wedge-shaped resilient tongs member. The illustrated wedge-shaped tongs can be formed by creating two slots past the elongate member in essentially the same manner as embodiments made of metal cannula. Baskets and tongs made of wedge tongs are advantageously compacted to a diameter smaller than the diameter of standard circular or flat wires, including fine "wedge wires, also published by Bagley et al. And patented to the current assignee. US Pat. No. 6,203,552, entitled "Inserting Retractor," is hereby incorporated by reference.

FIG. 6 shows a close up cross section showing the alternative embodiment of FIG. 3 in which the device is formed of a rigid member 62, wherein the resilient tongs 13 are essentially arcuate. These members are formed by creating a central bore 22 up to the distal end 20 of the rigid extension member towards a point at least close to where the proximal ends of the resilient tongs should be. Slot 15 is then formed to produce a compact 17 tweezers tweezers, formed in a widened mold 18 in the same manner as in the embodiment of FIG. The arcuate tong member of the FIG. 6 embodiment will generally have the same shape as if it were formed from a cannula, although the central bore would normally extend sufficiently or not beyond the proximal end of the elastic tong member. Forceps and baskets made of generally solid cylindrical stock will have a rigid shaft or proximal portion 21 without a central lumen and thus will not be able to supply additional instruments or devices.

The embodiments shown in FIGS. 1-8 disclose a retrieval device having four elastic tong members; Devices with two to eight tong members are possible. 9 is a view of an alternative embodiment of the retrieval device 10 of FIG. 1 having two elastic forceps members 13 formed by cutting a single slot. This type of retrieval device may be particularly useful as a snare 26 for retrieving an extended external object 52 such as a catheter, pacemaker leads, or the like.

FIG. 13 shows a cross section of an undeployed staggered embodiment of the device of FIG. 1 with three resilient tongs 13 formed of three slots 15. In this particular embodiment, the passageway forming three slots 47; 48, 49; 50, 51 creates an imaginary triangle in cross section. Here, "slot" refers to a single longitudinal opening through the cannula wall, and "path" refers to an imaginary line passing through two different slots in the cannula, indicating how the slot is formed. Thus a single slot may be assigned two different element numbers (i.e. 48,49 and 50,51). The first slot 47 is formed past the elongated cylindrical member so that the exit slot 48 is directed toward the first inlet slot 47 rather than facing the device having the same number of tong members. Is placed at 120 ° along the circumference of the cylinder. In order to make the third slot 30, the second inlet slot 49 is formed so that the inlet slot 49 or the second outlet slot 51 is already formed with the first inlet slot 47 or the first outlet slot 48. Same as). For example, the second passageway 49-51 has a second outlet slot 51 at 120 ° from the second inlet slot 49 / first outlet slot 48 and 120 ° from the first inlet slot 47. Can be precut through the first outlet slot 48 for the EDM wire to form. Any third outlet slot 50 can be made through a second outlet slot past the first inlet slot that completes the edge in the same manner; These two slots will already be formed. This method is not limited to an apparatus having three tong members. For example, a device having five tong members may require slots to be formed at 72 ° intervals along the circumference of a cylinder with a slot passage forming a virtual pentagon. An alternative method of forming an odd number of slots would be the technique described above, in which a rod is inserted and the slots are cut at the desired spacing rather than two formed in a single cut.

FIG. 14 shows a sectional view of an expanded, alternative embodiment of the retrieval device 10 of FIG. 1 having eight elastic forceps members 13. Such a basket is advantageous for capturing and maintaining small objects.

10 shows a side view of an alternative embodiment of the FIG. 1 recovery device 10, the distal end 20 is soldered and closed. The solder joint 27 inside the tip is finished by grinding and / or polishing. The polished tip prevents trauma to the fine tissue while using the device. Closing the distal end does not interfere with feeding the laser fiber or other device through the lumen to treat the stuck stone; An open distal end is advantageous if the ability to supply the device for the guidewire is desired.

FIG. 11 shows the side of the alternative recovery basket 54 of the device 10 of FIG. 1, wherein the distal cylinder 55 (cannula 60) is interconnected with the distal end 41 of the elastic forceps member 13. Fasteners 57, such as solder joints 27, are used. As used herein, fasteners 57 may be constructed in other known ways of joining elastic forceps members such as caps, crimps, bands, welding (including spot welding), or bonding. This method of engaging the elastic forceps member 13 provides an alternative method of making the recovery basket 69 so that the extension member 11 can be cut as in the embodiment of the forceps tweezers 23 shown in FIG.

15-16 illustrate another preferred embodiment of the present invention in which the elastic forceps member 13 of the retrieval device 10 is formed to produce a medical spiral retrieval basket 10. 15 is a side view of a spiral basket 54 having four undeployed wires with a spiral slot 15. These slots 15 may be formed in a manner similar to that of the FIG. 1 embodiment, with the difference being that slots 15 with a cutting means or cannula 60 are spiraled around the circumference of the cannula 60. To rotate. This manufacturing method can be adapted to the use of rigid wires. FIG. 16 shows a side view of the medical recovery device of FIG. 15: As in the non-helical embodiment, the elastic forceps members 13 may be provided with an extension member (with the forceps member 13 loosened and in an unpressed state or condition). 18) are manually organized.

17-18 are diagrams of an alternative embodiment of the device 10 of FIG. 1 that includes an actuating member 29 rather than an external restraint mechanism to open and close the basket to catch and hold the stones 24. In FIG. 17, the forceps member 13 is open enough to receive the stones 24 into the work space 28. FIG. 18 shows the drawing of the recovery device 10 of FIG. 16, with the operating member 29 sufficiently advanced to cause the distal end 20 to move distal and to close the resilient tongs 13 securely against the cannula 24. Illustrated. The distal end 42 of the actuating member 29 is soldered or otherwise attached to the distal end 20 of the device 10. The actuating member 29 is in a fully advanced position while the undeployed device is contained in an endoscope or introducer sheath. When the tong member 13 is revealed, the basket 54 can be manipulated by the open or widened mold 18 by being returned to the actuating member 29 and then locked in place. To close the basket, the actuating member 29 is effectively advanced completely to the closed position 30 to trap the stones 24. This actuating member 29 may be filled in place at the proximal end 38 of the device by a locking hub or other known means to prevent accidental discharge of stones during recovery from the body.

The actuating member somewhat limits the size of the working space 28 available to accept stones, but does not take into account the external sheath so that the device occupies a small lumen or has a coaxial device with a recovery basket 54 of the same diameter. It leads to more limited space. A small diameter actuating member may be used to allow gaps in the lumen of the appendage, or a second lumen may be provided in the elongate member 11 for that purpose. It is important that the operating member 29 must have sufficient rigidity while pushing forward the closure of the elastic forceps member without significant lateral bending of the rod. Since the position of the actuating member 29 relative to the cannula 60 controls whether the basket is opened or closed, the elastic forceps member 13, like other embodiments, is loosened and pressed while being widened or compact. May be in an unattended state. In this case, pulling the actuating member 29 associated with the cannula 60 causes the basket to pass through the widened mold 18, while the advancing actuating member moves the elastic forceps member 13 to the loosened compact form 17. Will revert.

19-21 show the most preferred embodiment of the recovery device 10 of the present invention in a series of first materials 40, including an elastic forceps member 13, closest to the forceps member 13. There are a number of reinforcing wires 31 interconnected with different materials 66 at the distal portion 37 of the elongate member 11. In an exemplary embodiment, the recovery device 10 consists of a plastic tube 32 having a flat elastic metal or plastic reinforcement wire 31 encased in the wall 16. By removing a portion of the plastic tube 32 from the distal portion 37 of the elongate member 11, the exposed reinforcing wire 31 is made into a widened mold 18 and then functions as an elastic forceps member 13.

FIG. 19 shows a recovery basket 10, which is a flat reinforcing wire 31 of the helical braided form 33 while the elastic tongs 13 are in the plastic tube 32. This resilient tongs 13 can be straightened as it turns or exits the distal end 56 of the plastic tube 32 or can follow the natural contour of the spiral braid 33. The tubing 32 may have fewer elastic forceps than the exposed reinforcing wire 31 by cutting some wires at the distal end 56 of the outgoing tube. In one example of a reinforced tube having eight braided wires, all spiral wires in one direction (i.e. spirally turning to the right) are cut and moved spirally in the other direction to form a spiral basket with four members. Leaves four exposed wires. The distal ends 41 may be coupled to a fastener 57, such as an end cap 34 or other known means. Another method of making the retrieval basket 54 is to place a portion of the original plastic tube 32 at a distal end, similar to the distal cylinder 55 in FIG. 1, interconnecting the distal end 41 of the elastic forceps member 13. It is left behind.

20 shows another preferred embodiment of the present invention whereby the reinforcing wires 31 are aligned in line with the longitudinal axis 43 of the elongate member 11 rather than being wound in a spiral. Baskets of this type usually do not have to reorient or cut the wire when exiting the distal end of the plastic tube 32.

FIG. 21 shows an embodiment of the device of FIGS. 18 and 19 in which the non-fixed elastic forceps members comprise forceps tweezers 32. The distal ends 41 of the elastic forceps members 13 can be deformed inwards to facilitate capturing and retaining the target object.

22 and 23 show an alternative embodiment of the device 10 of FIG. 1, wherein the distal portion 37 and the proximal portion 21 of the extension member 11 are formed as separate teeth connected to the junction 59.

With reference to FIGS. 24 and 25, the junction 59 between the distal portion 37 and the shaft 63 is defined as the first passage 12 of the distal portion 37 and the second passage of the shaft 63. 64 is maintained in a concentric arrangement along the longitudinal axis 43. The concentric arrangement of the first and second passages 12, 64 extends from the proximal end of the shaft 63 to the capture region 28 near the tongs member 13 past the entire device 10. 65). Shaft 63 is a tube braided with a flat wire consisting of flat wire conduits 71 that are hollow and braided to form bore 79 and are manufactured by HV Technologies, Trenton, GA. Is filled with a slippery material such as polyimide. The shaft 63 is cylindrical, extended by an epoxy resin 73 such as LOCTITE 4014, manufactured by Loctite Corp. a division of Henkel, Rocky Hill, CT, Connecticut, Rocky Hill, Henkel. It is held in the member 11.

Referring to FIG. 25, the polyimide fills the balanced wire braid 71 to form an inner sheath 70 and an outer sheath 72. The inner sheath 70 is proximate to form the second passageway 64. The flat wire metal braid 71 is preferably made from a metallic wire, such as a flat stainless steel wire braided with conduits to provide good strength and flexibility. Conduit braid 71 surrounds second passageway 64. When the braided wire 71 is in the tensioned state, the conduit contracts at another point so that the axial force to separate the shaft 63 at the distal portion 37 increases the contraction of the braid 71 at the distal portion 37. Affects.

With continued reference to FIG. 25, the distal portion 37 is machined to form a stepped portion 78 and a shoulder portion 81 of reduced outer diameter 74, adjacent the proximal end of the distal portion 37. The shaft 63 is also machined to remove a portion of the inner sheath 70 proximal to the distal end to form an increased portion of the inner diameter 75 along the bore 79 so as to have a flat wire in the second passage 64. The braid 71 may be exposed.

With continued reference to FIGS. 24 and 25, to form the junction 59, the proximal end of the distal portion 37 is inserted into the distal end of the shaft 63. The reduced outer diameter 74 of the distal portion 37 and the inner diameter 75 of the shaft 63 are approximately equal to each other. Braid 71 of shaft 63 is joined surrounded by stepped portions 78 of distal portion 37. An adhesive such as epoxy resin 73 forms a strong bond so that the two parts 37 and 63 do not decompose. When tensioned, braid 71 will catch distal portion 37 by compression in stepped portion 78. Referring also to FIG. 23, the coaxial relationship between the first lumen 12 and the second lumen 64 forming a continuous lumen 65 and reducing the outer diameter of the distal portion 37 in the stepped portion 78 is shown. At the junction 59, the distal portion 37 is concentrically fitted to the shaft 63 without substantially increasing the outer diameter 76 of the elongate member 11. In addition, since the diameter of the central lumen 65 is not affected by the junction 59, it forms the device 10 that maintains the minimum outer diameter 76 and the maximum inner diameter 77. In a preferred embodiment, the outer diameter 76 is approximately 3Fr (1 mm) and the inner diameter 77 is clad from at least .026 mm to .0365 mm, or the minimum referred to in this field as "slim line cladding". Can accommodate clad fiber optic cable.

With continued reference to FIGS. 24 and 25, the shaft 63 also includes an outer sheath 72 of slippery material, such as polyimide. The outer sheath 72 covers and protects the metal braid 71, along the accessory channel 46 of the scope 44 (FIG. 8), or inside the outer sheath 14 (FIGS. 7, 8 and 14). Reduces the frictional force that moves the shaft 63. The second passage 64 of the shaft 63 should be considered important for the use of a laser, ultrasound or other accessory device 25 for treating the stones 24 in the tongs of the retaining member 11. The metal braid 71 allows the strength of the stainless steel wire with the minimum wall thickness to the shaft 63 by using good stainless steel wire for the braid 71.

Referring now to FIG. 26, one embodiment of the present invention is shown, wherein the device 10 utilizes a handle 86 as is known in the medical recovery device art. The handle 86 has a sliding member 88 attached to the outer restraining member or the sheath 14. This sliding member 88 is slidably mounted to the handle body 92 such that a protrusion 90 from the sliding member 88 can be used to advance or retract the sliding member 88 with respect to the handle body 92. have. Slots 93 formed in the handle body 92 surface receive protrusions 90 and limit the movement of the sliding member 88 relative to the handle body 92. By manipulating the protrusion 90, the sheath 14 is closed (eg as shown in FIG. 2) or opened in a compact form 17 (eg as shown in FIG. 1) in an unfolded state ( 18) is moved with respect to the extension member for deforming the holding member.

With continued reference to FIG. 26, the shaft 63 extends beyond the sliding member 88 and is secured to the handle body 92 at the receiving adapter 94. Orifice 95 (FIG. 27) is formed at receive adapter 94 along axis 43. This orifice is formed, for example, in the stones 24 where the fiber optical cables 96 and 25 attached to the laser power source 98 are captured by the elastic forceps member 13 for breaking the stones 24 (FIG. 8). ) Aligned concentrically with the continuous lumen 65 to be inserted into the orifice through the continuous lumen 65 directing the laser energy, and the stones can then be removed from the patient. Optionally, continuous orifice 95 and subsequent continuous lumen 65 may be used to direct the crushed wire 99 from the ultrasonic power supply 100 to the stones 24.

The recovery device 10 of the present invention is preferably made of a medical material that can be sterilized by conventional procedures prior to use. Conveniently, this recovery device 10 may be made of relatively inexpensive synthetic and metallic materials, so that they can be disposed of after a single use, rather than being re-sterilized and regenerated. However, such reuse will also be considered within the scope of the present invention. Although passages 12 and 64 are described as being aligned along axis 43, forming a continuous central lumen 65, the lumen 65 does not extend along a straight line in this apparatus. The coaxial arrangement of the passages 12, 64 is essentially maintained when the device 10 is steered. The strength and flexibility of the shaft 63 attached to the distal portion 37 is thus a major feature of the present invention.

Of course, many of the details of the structure can be changed by applying the retrieval device 10 of the present invention to the particular surgery to be performed.

It will be apparent from the foregoing description that the recovery device 10 of the present invention is particularly advantageous in many respects over previous devices. Most importantly, the present invention is particularly advantageous over the prior art in that the device (and in particular the outer sheath) can have a total outer diameter that is significantly smaller than the outer diameter of current recovery or extraction devices. In addition, the recovery apparatus of the present invention may have an outer diameter as small as 1Fr (0.33 mm). The recovery device of the present invention is expected to capture, move, extract and / or recover stones, gallstones, foreign objects and the like from any point of the body much deeper than can be reached with existing devices. Baskets, tongs or other mating means formed of wedge-shaped cross-section wires have good torsional and bending resistance despite their small diameter and are made and maintained in a spiral shape, as indicated by the preferred embodiment of the present invention, as indicated in the preferred embodiment of the present invention. Can be. The small overall diameter possessed by the present invention will reduce the risk of the patient being traumatized during use.

As noted above, the recovery device of the present invention is expected to be used in a variety of procedures, including comparative procedures, bile ductal procedures, vascular procedures, and procedures for recovering foreign bodies from multiple body cavities. do. The retrieval devices of the present invention, also formed of cannula or tube, provide the ability to supply retrieval devices for guide wires that introduce laser fibers or other processing devices or facilitate placement within the body.

Details of the structure or tissue of the various components of the recovery device 10 that are not disclosed are not considered important to achieving the advantages of the present invention, as long as the elements have the strength or flexibility required to perform as specified. Choosing details of this structure is considered satisfactory within the context of this specification, even within the capabilities of one of the beginners in this field.

Claims (10)

An elongated cylindrical member having an extended passage therein and having a metallic proximal and distal portions and a recovery portion formed at the distal portion; Wherein the proximal and distal portions are formed into separate segments and connected to a junction; The elongated cylindrical member has a substantially constant inner and outer diameter range that extends through at least a portion of the proximal portion very close to the junction to a portion of the distal portion very near the junction. The medical device according to claim 1, wherein the elastic tong members of the expanded type are in a relaxed state in that the recovery part includes a plurality of elastic tong members that can be manipulated between the compact type and the expanded type. 3. The distal portion of claim 2, wherein the distal portion comprises a closed proximal cylinder and a closed distal cylinder, and the resilient tongs are joined at their proximal and distal ends by a closed proximal cylinder and a closed distal cylinder, respectively. Medical equipment. 4. The apparatus of claim 3, further comprising an external restraint mechanism for restraining the distal portion of the compactly extending cylinder member, the outer restraint mechanism alternately disposing elastic forceps members in the widened mold or capturing an object from the patient. A medical device, characterized in that it can slide longitudinally with respect to an elongated cylindrical member for recompressing an elastic forceps member having a shape that is expanded to either a substantially closed position or a compact shape for capture and withdrawal. 5. The tongs according to any one of claims 1 to 4, wherein at least in the distal region, the elongate member is substantially tubular and at which point the retractable member is formed in the distal portion by feeding at least one slot and / or at least one slit therein. Medical device comprising them. 6. The tongs member of any one of claims 2 to 5, wherein the tong members are made of a material (i.e., nitinol) which, when in a relaxed state, causes the members to be in an expanded configuration, or made to be able to be manipulated under stress on the expanded configuration Medical device, characterized in that formed. The system of any of the preceding claims, wherein one of the proximal and distal portions has an end comprising a reduced outer diameter area finishing at the shoulder portion; The other of the proximal and distal portions comprises a braided sleeve; And wherein the braided sleeve extends in the reduced outer diameter region such that the elongated cylindrical member has a continuous and concentric passage through the proximal and at least part of the distal portion. 8. A medical device according to claim 7, wherein the braided sleeve is at least partially covered with an outer sheath of slippery material, such as polyimide, or attached to the reduced outer area by an adhesive such as a medical epoxy resin. The medical device according to any one of the preceding claims, wherein the elongated member, with or without the external suppression mechanism, is designed to be relatively movable within the external tubular instrument, such as for example an endoscope, and to be suppressed by the device. In making the medical recovery apparatus of claim 7 or 8, Providing a distal portion with a reduced outer diameter area and an extended lumen therein; Providing a proximal portion comprising a hollow braided sleeve having an inner diameter approximately equal to the outer diameter of the reduced outer diameter region; Inserting a reduced outer diameter region inside the hollow braided sleeve to establish a substantially concentrically continuous lumen between them; Bonding at least one of the reduced outer diameter area and the hollow braided sleeve to ensure a connection therebetween.